Curriculum Vitae, John Douglas Hudson, M.D.

Transcription

1 CONTACT INFORMATION: Site Selection and Information: Bobbie Theodore, Alliance Director Tel. (916) Fax (208) EDUCATION: John Douglas Hudson, M.D. FutureSearch Trials of Neurology and Sleep Lab, L.P Parkcrest Drive, Suites 300 & 310 Austin, TX Doctor of Medicine University of Texas Medical Branch, Galveston, TX 1960 Masters Business Administration Northwestern University, Chicago, IL 1958 Bachelor of Arts, Major: Chemistry Texas Tech University, Lubbock, TX INTERNSHIPS AND RESIDENCIES: Neurology Residency University of Iowa, Iowa City, Iowa Medical Internship Methodist Hospital, Dallas, Texas Administrative Residency Brackenridge Hospital, Austin, Texas CERTIFICATIONS: Texas Medical Board License Number D0915 American Board of Sleep Medicine (Diplomat), 1999 American Academy of Sleep Medicine (Fellow) American Society of Neuro Rehabilitation (Diplomat), 1997 American Board of Neurology (Fellow), 1979 Updated 4/17/17 1

2 PROFESSIONAL EXPERIENCE: Medical Director and Advisor, 2012 Present online resource for subjects with sleep disorders Principal Investigator, 2001 Present FutureSearch Trials, Austin, TX Founder and President, Present Sleep Medicine Consultants, Austin, TX Hospital Staff, 1999 Present Brackenridge, St. David s, Seton, Texas NeuroRehab Center, Heart Hospital of Austin Private Practice, Neurology, 1967 Present Austin, TX Austin Neuro Diagnostics, 1975 Austin, TX Founder, 1970 Austin EEG and Neuroscience Laboratory, Austin, TX Founder, 1970 Austin Neurological Clinic, Austin, TX Medical Director Texas State University Sleep Lab, San Marcos, TX REM Sleep Center, Austin, TX CLINICAL RESEARCH EXPERIENCE: Phase I Age-Associated Memory Impairment (AAMI) Alzheimer s Disease Asthma Carpal Tunnel Syndrome Chronic Idiopathic Constipation Chronic Pain Chronic Obstructive Pulmonary Disease Delayed Sleep Phase Syndrome Dementia Diabetes (Type II) Diabetic Neuropathy Epilepsy Excessive Daytime Sleepiness Fibromyalgia Idiopathic Hypersomnia Insomnia Irritable Bowel Syndrome with Constipation or Diarrhea Low Back Pain Migraine Multiple Sclerosis Narcolepsy Neuropathic Pain Nonrestorative Sleep Opioid-Induced Bowel Dysfunction Obstructive Sleep Apnea/Hypopnea Syndrome Osteoarthritis Parkinson s Disease Polysomnography (PSG) Post Herpetic Neuralgia Restless Legs Syndrome (RLS) Shift Work Sleep Disorder Spasticity Stuttering Tinnitus Tourette s Disorder Traumatic Brain Injury ADDITIONAL TREATMENT EXPERIENCE: Hypertension Hyperlipidemia Obesity Stroke and Stroke Prevention Updated 4/17/17 2

3 CLINICAL TRIAL EXPERIENCE: Phase I Insomnia A Phase I study designed to obtain consumer preference feedback on an integrated continuous positive airway pressure (CPAP)/mask system and the marketing materials created for this product A Multicenter, Open-label Study to Determine the Effects of XXX on Sleep in Healthy Subjects Alzheimer's Disease An Open-Label, Extension Study of the Effects of XXX in Subjects with Alzheimer s Disease or Behavioral Variant Frontotemporal Dementia Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Month Trial of XXX in Subjects with Mild to Moderate Alzheimer's Disease (2 studies: Study A: Multinational, Randomized, Double blind, Placebo controlled, Parallel Group, 18 month, Study of XXX in patients with Mild Alzheimer's Disease Study B: Randomized Double blind, Placebo-controlled, Parallel group, 52 week study of 2 dose levels of XXX in pts w/treated or untreated Mild to Moderate Alzheimer's Disease ) Cognition A Phase II, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing XXX with Placebo in Subjects with Age-Associated Memory Impairment (AAMI) Epilepsy Pilot Study to Evaluate a Baseline Prototype Device Designed to Collect ECG (Electrocardiogram) and Accelerometer Data A Prospective Randomized 12-week Controlled Study of Visual Field Change in Subjects with Partial Seizures Receiving XXX or Placebo A Phase III, 12-month, Open-label Study Evaluating the Safety and Tolerability of Flexible Doses of XXX as Adjunctive Therapy in Pediatric Patients Ages 1 month to 16 years with Partial Onset Seizures and Pediatric and Adult Patients Ages 5 to 65 years with Primary Generalized Tonic-Clonic Seizures A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial of XXX Controlled Release Formulation as Adjunctive Therapy in Adult Subjects with Partial onset Seizures Updated 4/17/17 3

4 A Multi-center, Open-Label Study to Assess the Efficacy of as First Add-on Treatment in Adult Patients (17-65) with Partial-Onset Seizures. This Phase III b/iv Study will Assess Two Groups of Epilepsy Patients: Patients who are Not Responding to Monotherapy Anti-Epileptic Drug (AED) Treatment (Diagnosis 12 Months); OR Patients who Have Not Responded to More Than Two Treatments (Diagnosis 5 Years) A Randomized, Double-Blind, Parallel-Group, Multi-center Study to Evaluate the Retention Rate, Efficacy, Safety, and Tolerability of XXX, XXX, and XXX as Adjunctive Therapy in Subjects with Partial Onset Seizures A 9-11 Week Multi-center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Effects of Adjunctive XXX on the Sleep Architecture of Adult Subject (18 45 Years of Age) with Partial Onset Epilepsy Receiving a First Generation Anti-Epileptic Drug Fibromyalgia An Open-label Extension Study of XXX for 52 weeks in Pain Associated with Fibromyalgia A randomized, double-blind, double-dummy, placebo- and active-controlled, multi-center study of XXX in subjects with pain associated with fibromyalgia A Phase IIIb Multicenter, Double-blind, Randomized, Placebo-controlled, 2-way Crossover Study of XXX in the Treatment of Fibromyalgia with Concurrent Antidepressant Therapy for Comorbid Depression A Comprehensive Evaluation of Impacts and Possible Outcome Assessments A Phase III Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Study of Once Daily Controlled Release XXX in the Treatment of Patients with Fibromyalgia A Phase II, Multicenter, Open-label, 52-Week Extension Study to Evaluate the Safety and Efficacy of XXX in Pediatric Patients With Primary Fibromyalgia A Phase II, Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of XXX in Pediatric Patients With Primary Fibromyalgia A Safety and Tolerability Study Comparing XXX Given as an Oral Solution to a Single-Blinded Combination of Oral Tablets Plus Oral Solution in Subjects with Fibromyalgia A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study of XXX o Evaluate Responsiveness of, and Estimate the Clinically Important Difference in, a Novel Fatigue Tool in Subjects with Fibromyalgia Updated 4/17/17 4

5 The Safety and Tolerability Study Comparing XXX Given as an Oral Solution to a Single- Blinded Combination of Oral Tablets Plus Oral Solution in Subjects with Fibromyalgia A Randomized Evaluation of a Low Frequency Investigational Device Employing Neuromodulation Therapy in Patients with Fibromyalgia: A Double-Blind, Placebo-Controlled Trial A Multi-center, Randomized, Double-Blind, XXX-Referenced, Placebo-Controlled, Parallel- Group, Adaptive Design Study of XXX in Adult Female Outpatients with Fibromyalgia Syndrome A Multi-center, Multiple Dose, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of XXX in Female Patients with Fibromyalgia Syndrome A Six-Month Open Label Extension Study of the Long-Term Safety of the XXX in Outpatient with Fibromyalgia Syndrome A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adaptive- Design, Efficacy, Safety and Tolerability Study of 4 Fixed Oral Doses of XXX in Adult Outpatients with Fibromyalgia Syndrome Insomnia A Phase III, multicenter, 12-month, randomized, double-blind, controlled study to evaluate the safety and efficacy of XXX in subjects 18 years or older with insomnia disorder. Subjects must report complaints regarding both sleep onset AND sleep maintenance. A Phase II, Randomized, Placebo-Controlled, DoubleBlind, Fixed-Dose, Multiple Cohort, Multiple Crossover, Dose-Finding Study of Oral XXX in Adults with Idiopathic Hypersomnia or Narcolepsy Type 2 A Phase II Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of XXX in Adults and Elderly Subjects with Chronic Insomnia A12-Month, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of XXX as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Tramatic Brain Injury A Phase III, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Polysomnography Study to Evaluate the Safety and Efficacy of XXX in [adults and] Elderly Patients with Primary Insomnia Updated 4/17/17 5

6 A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multi-center Outpatient Trial of XXX in Adults with Nonrestorative Sleep A Phase III, Efficacy and Safety of XXX in Insomnia Characterized by Sleep Maintenance Difficulties: A Six-Week, Randomized, Double-Blind, Placebo-Controlled, Polysomnography (PSG) Study A Randomized, Double-Blind, Placebo-Controlled Subjective Study to Assess the Efficacy of XXX in Patients with Primary Insomnia characterized by Difficulty in Maintaining Sleep A Phase II Randomized, Double-Blind, Placebo-and Active-Comparator-Controlled Study of the Safety and Efficacy of XXX in Outpatients with Insomnia A Double-Blind, Randomized, Parallel Group, Placebo-Controlled Sleep Laboratory Efficacy and Safety Study with XXX in Elderly Subjects with Chronic Primary Insomnia A Fifty-Two Week Open Label Extension Trial, to Evaluate the Efficacy and Safety of XXX Trial in Outpatients with Chronic Primary Insomnia who Completed Clinical Trial A Multi-center Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of XXX in the Treatment of Primary Insomnia An Efficacy and Safety of XXX on Sleep Maintenance Insomnia with a Sub-Study of the Effect of XXX on Stable Type II Diabetes Mellitus: A One Year, Multi-center, Randomized, Double- Blind, Placebo-Controlled Study A Six Week, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Efficacy and Safety, Sleep Lab Trial with XXX Trial in Patients with Chronic Primary Insomnia A Randomized, Double Blind, Placebo-Controlled Study to Determine the Long-Term Efficacy and Safety of XXX in Adults with Chronic Insomnia The Safety and Efficacy of XXX Taken in Combination with XXX A 28-Day, Polysomnographic and Subjective Assessment of XXX for the Treatment of Primary Insomnia: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial A Multi-center, Randomized, Double Blind, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of XXX and Matching Placebo in Healthy Male and Female Subjects with Induced Transient Insomnia A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-center Proofof-Concept Study to Evaluate the Safety and Efficacy of XXX Taken in Combination with XXX for the Treatment of Subjects with Chronic Insomnia Updated 4/17/17 6

7 A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Long-Term Efficacy and Safety of XXX in Adults with Chronic Insomnia A Randomized, Double-Blind, Palcebo-Controlled, Cross-Over Study to Eveluate the Effects of XXX on Polysomnographic Sleep Recordings, Subjective Sleep Assessment, and Daytime Cognitive Function in Elderly and Nonelderly Subjects with Primary Insomnia An Efficacy and Safety of XXX on Sleep Maintenance Insommia: A 12-Week Multi-center, Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Treatment Phase Extension with XXX for 40 Weeks Period A Randomized, Double-Blind, Placebo-Controlled, Three-Way Cross-Over Study of XXX in Patients with Insomnia A Randomized Double-Blind Comparison of XXX, XXX, and Placebo in the Treatment of Patients with Primary Insomnia An Evaluation of the Long-Term Efficacy and Safety of XXX Compared to Placebo, When Both Are Administered Over a Long-Term Period As Needed, in Patients with Chronic Primary Insomnia. (A Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multi-center, Phase IIIb Clinical Study) A Four-Week, Multi-center, Phase IIB Double-Blind, Placebo-Controlled, Randomized, Multiple Dose, Parallel-Group Study of the Efficacy and Safety of XXX Tablets in the Treatment of Sleep Maintenance Insomnia A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-center, Study of XXX in Healthy Adult Volunteers Participating in a Four-Hour Phase Advance Model of Transient Insomnia A Randomized, Four-Way Cross-Over, Double-Blind, Placebo-Controlled, Multi-center Dose- Finding Trial with Three Dosages of XXX in Patients with Primary Insomnia A Six-Month, Chronic Efficacy and Safety Study of XXX in Adult Subjects with Primary Insomnia: A Randomized Double-Blind, Placebo-Controlled Study A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Assess the Efficacy and Safety of a Modified Release Formulation of XXX in Elderly Primary Insomnia Patients with Sleep Maintenance Difficulties A Randomized Double-Blind, Placebo-Controlled Paralled, Two-Week Objective Efficacy and Safety Study of XXX in Elderly Subjects with Primary Insomnia Updated 4/17/17 7

8 A Phase III, Randomized, Double-Blind, Placebo-Controlled, PSG Plus Outpatient Study to Determine the Safety and Efficacy of XXX in Adults with Chronic Insomnia A Phase III, Open-Label, Fixed-Dose Study to Determine the Safety of Long Term Administration of XXX in Subjects with Chronic Insomnia A North American, Four-Week, Multi-center, Phase IIB Double-Blind, Placebo-Controlled, Randomized, Multiple Dose, Parallel-Group Study of the Efficacy and Safety of XXX Tablets in the Treatment of Sleep Maintenance Insomnia A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Assess the Efficacy and Safety of A Modified Release Formulation of XXX in Adult Primary Insomnia Patients with Sleep Maintenance Difficulties A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Assess the Long-Term Safety and Efficacy of Two Dose Levels of XXX in Adult Patients with Primary Insomnia A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Assess the Efficacy and Safety of a Modified Release Formulation of XXX in Adult Primary Insomnia Patients with Sleep Maintenance Difficulties A Phase III, Open-Label, Outpatient, Extension Study to Assess the Long-Term Safety of a Modified Release Formulation of XXX in Adult Primary Insomnia Patients with Sleep Maintenance Difficulties A Phase III, Randomized, Double-Blind Placebo-Controlled, PSG Plus Outpatient Study to Determine the Safety and Efficacy of XXX in Adults with Chronic Insomnia A Phase III, Open-Label, Fixed-Dose Study to Determine the Safety of Long Term Administration of XXX in Subjects with Chronic Insomnia A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Assess the Long-Term Safety and Efficacy of Two Dose Levels of XXX in Adult Patients with Primary Insomnia The Comparison of Efficacy and Safety of XXX and Placebo in Patients with Primary Insomnia. A Double Blind, Randomized, Placebo-Controlled, Parallel Group Study Migraine A Phase III, Multicenter, Randomized, Double-Blind, Placebo Controlled, Efficacy, Tolerability, and Safety Study of XXX in Episodic Migraine With or Without Aura Updated 4/17/17 8

9 A Multicenter, Randomized, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral XXX in the Acute Treatment of Migraine With or Without Aura A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Single Attack Study to Evaluate the Efficacy, Safety and Tolerability of Oral XXX in the Acute Treatment of Migraine A Phase III, Open-label, LonG-term, Safety Study of XXX (100 mg and 200 mg) in the Acute Treatment Of MigRaine A Phase III, Study of Three Doses of XXX (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine: A Randomized, Double-blind, Placebo-controlled Parallel Group Study An Observational Research Study: Prospective Cohort Study to Describe Patient-Reported Outcomes in Subjects with Migraine Eligible for Prophylaxis A Phase III, Multicenter, Randomized, Double-Blind, Parallel-Group Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Subcutaneous Administration of XXX for the Preventive Treatment of Migraine A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 dose regimens of subcutaneous administration of XXX versus Placebo for the Preventive Treatment of Episodic Migraine A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 dose regimens of subcutaneous administration of XXX versus Placebo for the Preventive Treatment of Chronic Migraine A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of XXX in Patients with Chronic Migraine the XXX Study A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of XXX in Patients with Episodic Migraine the XXX Study A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of XXX in Migraine Prevention An Phase II Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of XXX in Chronic Migraine Prevention A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of XXX in Chronic Migraine Prevention Updated 4/17/17 9

10 A Phase III Randomized, Multicenter, Double-Blind, Placebo Controlled, Two-Arm Study Evaluating Efficacy of a Single Dose XXX (10 mg vs. Placebo) in Patients with Acute Migraine Headache With or Without Aura A Phase IIb, Randomized, Doub-Blind, Placebo-Controlled Study of XXX in Patients with Episodic Migraine A Phase II, Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Multi-dose Study to Compare the Efficacy and Safety of Subcutaneous XXX with Placebo for the Preventive Treatment of Chronic Migraine A Phase II,Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Study Comparing the Efficacy and Safety of Two Doses of Subcutaneous XXX with Placebo for the Preventive Treatment of High Frequency Episodic Migraine (HFEM) A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of XXX in Episodic Migraine Prevention, Dosed monthly by subcutaneous (SC) injection. A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of XXX in Patients with Migraine A Phase IIb Double blind Randomized Placebo controlled, Dose-ranging Trial of XXX for the Acute Treatment of Migraine A Safety, Tolerability, and Efficacy Study of XXX in the Treatment of Acute Migraine Headache Pain A Phase IIa, Multicenter, Randomized, Double-blind, Placebo-controlled and Active-controlled, Parallel-group Study Evaluating the Analgesic Efficacy and Safety of XXX in Subjects with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee A Phase II, Randomized, Double-Blind, Placebo-Controlled, Titration-to-Effect Study of Orally Administered XXX in Patients with Osteoarthritis of the Hip or Knee A Phase III, Open-Label, Long-Term Safety and Tolerability Study of XXX in Patients with Irritable Bowel Syndrome with Constipation (IBS-C) An Open-label Phase III Trial to Evaluate the Safety and Tolerability of XXX Tablet, in Patients with Moderate-to-Severe Chronic Noncancer Pain Updated 4/17/17 10

11 A Second Phase III, Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of XXX in Patients with Irritable Bowel Syndrome with Constipation (IBS- C) A Phase III, Open-Label Extension (OLE), Long-term Safety and Tolerability Study of XXX in Patients with Chronic Idiopathic Constipation (CIC) A Phase III, Randomized, Double Blind, Placebo and Active-Controlled, Multicenter, Parallel- Group Study of the Analgesic Efficacy and Safety of XXX in Adult Patients with Chronic Low Back Pain A Phase II, Double-blind, Placebo-controlled, Randomised Dose Ranging Trial to determine the safety and efficacy of two dose levels of XXX (angiotensin II type 2 receptor antagonist) administered orally in patients with postherpetic neuralgia A Phase III Multicenter, Open-Label, 52-week study to Evaluate the Long Term Safety and Tolerability of XXX in Subjects with Moderate to Severe Chronic Noncancer Pain A Phase III Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of XXX in Opioid-Naïve Subjects with Moderate to Severe Chronic Low Back Pain A Safety and Efficacy Evaluation of XXX Laxative in Constipated Adults A Phase IIa, Randomized, Double-Blind, Multicenter, Placebo and Active-Controlled Study to Assess Analgesic Efficacy and Safety of XXX in Subjects with Painful Diabetic Peripheral Neuropathy A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied XXX Ointment in Patients with Postherpetic Neuralgia A Randomized Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase III Study to Evaluate the Long-term Safety of XXX for the Treatment of Opioid-induced Constipation in Subjects with Non-malignant Chronic Pain Receiving Opioid Therapy A Double-blind, Randomized, Vehicle-controlled, Parallel-group Evaluation of XXX and Vehicle Nasal Sprays in the Treatment of Postherpetic Neuralgia of the Trigeminal Nerve A National, Randomized, 12-Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of XXX (3.0 and 6.0 mg) in Patients with Chronic Idiopathic Constipation A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Safety and Efficacy of XXX in Subjects with Type 2 Diabetes and Diabetic Peripheral Neuropathy Updated 4/17/17 11

12 A Phase III, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of XXX in the Treatment of Opioid-induced Constipation in Subjects with Non-malignant Pain Receiving Opioid Therapy A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of XXX in Subjects with Postherpetic Neuralgia A Phase II Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Using a Bayesian Adaptive Design to Assess the Efficacy, Safety, Tolerability, and Serum Exposure of Multiple Doses of XXX in Subjects with Painful Lumbar Radiculopathy An Phase III open-label extension study of up to 52 weeks to assess the safety, tolerability, and analgesic efficacy of XXX in the management of moderate to severe chronic pain requiring ATC opioid analgesia for an extended period of time A Phase III, 6-Month, Open-Label, Extension Study to Evaluate the Safety of XXX at 15 to 90 mg Every 12 Hours for Relief of Moderate to Severe Pain in Patients With Chronic Low Back Pain Who Require Opioid Treatment for an Extended Period of Time A Phase III, 12-Week, Randomized, Double-Blind, Placebo-Controlled, Randomized- Withdrawal Study to Evaluate the Efficacy and Safety of XXX at 30 to 90 mg Every 12 Hours for Relief of Moderate to Severe Pain in Opioid-Experienced Patients With Chronic Low Back Pain Who Require Opioid Treatment for an Extended Period of Time A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Safety and Efficacy of XXX in Patients with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee A Phase II, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Study Evaluating the Analgesic Efficacy and Safety of XXX in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN) pursuant to Protocol XXX A Phase III, Double-blind, Placebo-controlled, Multicenter, Randomized Withdrawal Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of XXX in Opioid-Experienced Subjects with Moderate to Severe Chronic Low Back Pain Requiring Around-the-clock Opioid Analgesia for an extended period of time A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Efficacy Study of XXX Versus Placebo in Opioid-Experienced Subjects with Moderate to Severe Chronic Low Back Pain A Phase III Open Label Safety Study of XXX in Subjects with Osteoarthritis or Chronic Low Back Pain Updated 4/17/17 12

13 A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of XXX for the Treatment of Opioid-Induced Constipation in Adults taking Opioid Therapy for Chronic Non-Cancer Pain AND A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Long-Term Safety and Tolerability of XXX for the Treatment of Opioid-Induced Constipation in Adults taking Opioid Therapy for Chronic Non-Cancer Pain A Phase III, Double-blind, Placebo-controlled, Multicenter, Randomized withdrawal Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of XXX in Opioid-naïve Subjects with Moderate to Severe Chronic Low Back Pain Requiring around-the-clock Opioid Analgesia for an Extended Period of Time A Phase II Study, Assessing the Content Validity of XXX in Patients with Chronic Opioid- Induced Constipation An Open-label Evaluation of XXX Extended Release (ER) in Subjects with Moderate to Severe Chronic Pain Following Conversion from XXX A Multi-center, 12-week, Double-blind, Placebo-controlled, Randomized Withdrawal Study to Determine the Efficacy and Safety of XXX Extended-release Capsules in Subjects with Moderate to Severe Chronic Low Back Pain A Phase IV, Randomized, Double-Blind, Parallel-Arm Clinical Trial to Compare the Clinical Effectiveness of XXX vs. XXX in Subjects with Moderate to Severe Low Back Pain A Phase IIa, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Safety and Efficacy of XXX in Patients with Painful Diabetic Neuropathy A Randomized, Double-Blind, Placebo and Active Comparator-Controlled Study of XXX for Treatment of Neuropathic Pain Associated with Diabetic Peripheral Neuropathy A Phase II, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallelgroup Study of Efficacy and Safety of XXX 20MG and 120MG Twice Daily for 4 Weeks in Patients with Chronic Peripheral Neuropathic Pain A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallelgroup, Multicenter Trial of XXX controlled-release Tablets to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to XXX ) in Opioid-experienced Subjects with Controlled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation who Require Around-the-clock Opioid Therapy Updated 4/17/17 13

14 A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallelgroup, Multicenter Trial of XXX controlled-release Tablets to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to XXX ) in Opioid-experienced Subjects with Uncontrolled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation who Require Around-the-clock Opioid Therapy An Open Label, Safety and Tolerability Study of Multi-Layer, Extended-Release Tablets of XXX in the Treatment of Patients with Moderate to Severe Acute Pain of Up to 30 Days, of Non-Malignant Origin A Phase IV, Open Label, Study of Safety and Effectiveness of XXX Tablets in the Treatment of Patients with Post herpetic Neuralgia in Clinical Practice A Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open-label Run-in to Assess the Efficacy and Safety of XXX Tablets Once-daily in Subjects with Moderate to Severe Chronic Low Back Pain A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of XXX for the Treatment of Opioid-induced Constipation (OIC) in Subjects with Non-malignant Chronic Pain Receiving Opioid Therapy Qualitative Study to Assess the Content Validity of the Modified Insomnia Severity Index (ISI) in Chronic Pain Patients A Open-label, Multicenter Study to Assess the Long -term Safety of XXX Tablets 20 to 120 mg Once-daily in Subjects with Moderate to Severe Chronic Nonmalignant and Non-neuropathic Pain Open Label Long Term Safety Study: An Open-Label Study to Assess the Long-Term Safety of XXX in Patients with Opioid-Induced Constipation (OIC) A Randomized, Double-blind, Placebo-controlled, Multicenter Trial with an Enriched Study Design to Assess the Efficacy and Safety of XXX Controlled-release Tablets Compared to Placebo in Opioid-experienced Subjects with Moderate to Severe Pain due to Chronic Low Back Pain who Require Around-the-clock Opioid Therapy Validation of Short Treatment Satisfaction Questionnaire for Use in Neuropathic Pain Patients Treated with XXX A Phase II, 52-week, Open-label, Long-term Treatment Evaluation of the Safety and Efficacy of XXX in subjects with moderate to severe Chronic Pain Updated 4/17/17 14

15 A Multicenter, Double-blind, Placebo-controlled, Cross-over Study of the Safety and Efficacy of XXX in Patients with Post-herpetic Neuralgia (PHN) A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XXX in Patients with Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC) A Phase IV Multi-center, Primary Care-Based, Open-Label Study to Assess the Success of Converting Opioid-Experienced Patients, with Chronic, Moderate to Severe Pain, to XXX Using a Standardized Conversion Guide, and to Identify Behaviors Related to Prescription Opioid Abuse, Misuse, and Diversion A Phase III, Multicenter, 12-Month, Open-Label, Single-Arm, Safety Study of XXX and XXX Extended-Release Capsules in Subjects With Moderate to Severe Chronic Non-cancer Pain A 12-week placebo-controlled, double-blind, randomized withdrawal study to evaluate the efficacy and safety of XXX in subjects with moderate to severe chronic low back pain A Multi-center, Double-Blind, Randomized, Placebo-controlled, Repeat Treatment (two cycle) Study of the Safety and Efficacy of XXX in Patients with Postherpetic Neuralgia A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Two-Treatment, Two-Period Cross-Over Study to Evaluate the Safety Tolerability, Preliminary Efficacy and Systemic Exposure of XXX in Patients with Post Herpetic Neuralgia A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Two-Treatment, Two-Period Cross-Over Study to Evaluate the Safety Tolerability, Preliminary Efficacy and Systemic Exposure of Topical XXXin Patients with Post Herpetic Neuralgia A Randomized, Double-Blind, Placebo-Controlled, Multi-center Trial with an Enriched Study Design to Assess the Efficacy and Safety of XXXCompared to Placebo in Opioid-experienced Subjects with Moderate to Severe Chronic Low Back Pain A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Dose Study of the Safety and Efficacy of Subcutaneously Administered XXX in Patients with Osteoarthritis of the Knee A Multi-center, Double-Blind, Randomized, Placebo-Controlled, Repeat Treatment (two cycle) Study of the Safety and Efficacy of XXX in Patients with Post-herpetic Neuralgia A Randomized, Double-Blind, Placebo-Controlled with Open-label Run-in Assessing Efficacy, Tolerability, Safety of XXX Compared to Placebo in Opioid-Naïve Subjects with Moderate to Severe, Chronic Pain Due to OA of the Knee Updated 4/17/17 15

16 A Phase III Randomized, Double-Blind, Placebo-Controlled, Multi-center Study of the Analgesic Efficacy and Safety of the Subcutaneous Administration of XXX in Patients with Osteoarthritis of the Knee A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of XXX in Patients with Chronic Low Back Pain A Phase IIb, Randomized, Double-Blind, Two-Arm, Multi-center, Placebo-Controlled, Study to Assess the Efficacy and Safety of XXX in Subjects with Moderate to Severe Chronic Low Back Pain (CLBP) A Phase IIa, Randomized, Blinded, Placebo- and Active-controlled, 2-Period Crossover Study to Assess the Analgesic Efficacy, Safety, and Tolerability of XXX in Subjects with Post herpetic Neuralgia A Randomized, center, Double-Blind, Parallel-Group Trial with Controlled Adjustment of Dose Assessing the Analgesic Efficacy and Safety of a New Analgesic Compared with Placebo in Subjects with Painful Diabetic Peripheral Neuropathy An Open-Label 52-Week Safety Study of SR XXX in Adult Outpatients with Chronic Neuropathic Pain Associated with Diabetic Peripheral Neuropathy A Double-Blind, Randomized, Parallel-Design, Placebo-Controlled, Multi-center, Study of Two Doses of XXX in Adult Outpatients with Pain Associated with Chronic Diabetic Neuropathy A Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Effect of XXX at Two Doses for 24-Weeks Treatment on the Rate of Regeneration of Epidermal Nerve Fibers in Patients with Mild Diabetic Peripheral Neuropathy A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of XXX in Subjects with Diabetic Painful Neuropathy and Small Fiber Neuropathy Associated with Impaired Glucose Tolerance Followed by a Double-Blind Safety Extension and an Open Label Safety Extension The Investigation of the Efficacy and Pharmacokinetics of XXX in Subjects with Neuropathic Pain Associated with Post-Herpetic Neuralgia (PHN) Who Have Had an Inadequate Response to XXX Treatment A Phase III Multi-center, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study of the Safety and Efficacy of XXX Tablets in the Treatment of Patients with Post-herpetic Neuralgia ( Study ) in accordance with Sponsor s Protocol Updated 4/17/17 16

17 A Double-Blind, Placebo-Controlled, Randomized, Parallel Group Study Evaluating the Efficacy and Tolerability of Oral Medication TID, Versus Placebo in the Treatment of Post Herpetic Neuralgia A Phase III Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Once-Daily XXX Extended Release Tablets in the Treatment of Patients with Post-herpetic Neuralgia A Randomized, Double-Blind Study Comparing the Safety and Efficacy of the XXX Patch 5% with Placebo in Patients with Pain from Carpal Tunnel Syndrome A Phase II Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Dose-Loading Study to Evaluate the Efficacy, Safety, and Tolerability of XXX in Subjects with Moderate to Severe Chronic Low Back Pain A Phase II Randomized, Double-Blind, Multi-Dose, Active- and Placebo-Controlled, Multicenter, Parallel Group Study of the Analgesic Effect of XXX in Adult Patients with Chronic Low Back Pain A Phase III, Randomized, Double-Blind, Placebo- and Active-Control, Parallel-Arm, Phase III Trial with Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of XXX Extended-Release (ER) in Patients with Moderate to Severe Chronic Low Back Pain A Phase III Multi-center, Randomized, Double-Blind, Placebo-Controlled Study with an Open- Label Run-In to Assess the Efficacy, Tolerability, and Safety of XXX or XXX Compared to Placebo in Opioid-Naïve Subjects with Moderate to Severe, Chronic Pain Due to Osteoarthritis of the Knee A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of XXX in Subjects with Moderate to Severe, Chronic Knee or Hip Pain From Osteoarthritis Parkinson s Disease A Phase III, Double-Blind, Placebo-Controlled, Randomized Study Comparing the Efficacy, Safety, and Tolerability of XXX Agonist Versus Placebo in Patients with Early Parkinson s Disease An Open-Label, Long Term, Flexible Dose Study of Safety, Tolerability, and Therapeutic Response in Patients with Parkinson s Disease The Safety and Efficacy of XXX in the Treatment of Patients with Psychosis Associated with Parkinson's Disease Updated 4/17/17 17

18 A Phase IIIb, Randomized, Double-Blind, Double-Dummy XXX-Controlled, Parallel Group Study of Two Years Treatment with XXX or XXX as Adjunctive Therapy in Patients with Parkinson s Disease Not Optimally Controlled on XXX Restless Legs Syndrome A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group Study to Compare the Efficacy, Tolerability, and Safety of 3 Doses of XXX With Placebo in the Treatment of Subjects With Moderate-to-Severe Primary Restless Legs Syndrome A Phase IIIb, Double-blind, Randomized, Placebo-controlled Study of XXX and it s Effect on All-day Fuctioning and Quality of Life in Subjects with Moderate to Severe Idiopathic Restless Legs Syndrome A Phase IIIb multi-center, randomized, double-blind, placebo-controlled, parallel-group, polysomnography (PSG) study to investigate safety and efficacy of the XXX in subjects with restless legs syndrome and end-stage renal disease requiring hemodialysis A Randomized, Double-blind, Placebo-controlled, Safety and Efficacy Study of XXX in the Treatment of Moderate to Severe Restless Legs Syndrome (RLS) A Multicenter, Open-label, 2-group, Dose Escalation Study of Monotherapy Administration of XXX in Pediatric Subjects with Idiopathic Restless Legs Syndrome A Phase II, Open-label, Long-term, Follow-up Study to determine the Safety, Tolerability and Efficacy of XXX as Monotherapy in Adolescents with Restless Legs Syndrome A Fixed Dose Randomized, Double-Blind, 12-week Study of XXX Subjects with Moderate to Severe Idiopathic Restless Legs Syndrome A Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover, Multi-center Polysomnography Study of XXX and XXX in Adults with Restless Legs Syndrome A Fixed-dose, Randomized, 12-Week Placebo-Controlled, 52-week Comparator-Controlled, Double-Blind Study to Assess the Rates of Augmentation, Efficacy and Safety of XXX and XXX in Subjects with Moderate to Severe Idiopathic RLS An Open-Labeled, 52-Week Extension Study Assessing XXX Safety and Efficacy in Patients with Restless Legs Syndrome A Phase II, Double Blind, Placebo-Controlled, Randomized, Parallel-Group, Multi-center, Study to Evaluate the Efficacy and Safety of XXX in Subjects with Restless Legs Syndrome (RLS) Updated 4/17/17 18

19 A Four-Week, Randomized, Double-Blind, Cohort Study to Evaluate the Safety and Tolerability of Converting From XXX Immediate Release (IR) to XXX Extended Release (XR) Formulation in Patients with Restless Legs Syndrome (RLS) A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Five-Arm Parallel-Group Trial to Investigate the Efficacy and Safety of Four Different Transdermal Doses of XXX in Subjects with Idiopathic Restless Legs Syndrome An Open-Label Extension Trial to Investigate the Safety and Tolerability of Long-Term Treatment with Transdermal XXX in Subjects with Idiopathic Restles Legs Syndrome A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XXX in Patients with Restless Legs Syndrome A 12-Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of XXX in Patients Suffering From Restless Legs Syndrome (RLS) A 12-Week Double-Blind, Placebo Controlled Study to Assess the Tolerability, Efficacy and Safety of XXX Dosed PRN in Subjects with Restless Legs Syndrome (RLS) who Respond to Open-Label Treatment with XXX A 12-Week, Double-Blind, Placebo Controlled, Twice Daily Dosing Study to Assess the Efficacy and Safety of XXX in Patients Suffering From Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage Sleep Disorders A Phase III, Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of XXX in Subjects with Narcolepsy with Cataplexy A Phase III, Long-Term, Open-Label Safety and Maintenance of Efficacy Study of XXX in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy or Obstructive Sleep Apnea A Phase III, Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of XXX in the Treatment of Excessive Sleepiness in Subjects with Obstructive Sleep Apnea (OSA) A Phase III, Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study of the Safety and Efficacy of XXX in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy A Phase II/III Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of XXX with an Open-Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects with Narcolepsy with Cataplexy Updated 4/17/17 19

20 A twelve-week, double-blind, placebo-controlled, randomized, parallel-group, multi-center study of the safety and efficacy of XXX in the treatment of excessive daytime sleepiness in subjects with narcolepsy A Four-week, Double-blind, Placebo-controlled, Randomized, Cross-over Study of the Safety and Efficacy of XXX in the Treatment of Excessive Daytime Sleepiness A Phase III, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of XXX Treatment in Children and Adolescents with Excessive Sleepiness Associated with Narcolepsy A Short-Term (Eight-Week) Open-Label Study, Followed by a Long Term Evaluation, to Assess Patient-Reported Outcomes with XXX Treatment for Excessive Sleepiness in Adults with Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome A Randomized Phase II, Double-Blind, Placebo-Controlled, Multi-center Crossover Study of XXX as a Daily Treatment for Excessive Daytime Sleepiness (EDS) Associated with Narcolepsy A One-Year Open Label, Flexible Dosage Extension Study to Assess the Safety and Continued Effectiveness of XXX Treatment in Children and Adolescents with Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea/ Hypopnea Syndrome A Phase III, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of XXX Treatment in Children and Adolescents with Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea Syndrome A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of XXX at a Target Dosage of XXX as Treatment for Adults with Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea Syndrome with Comorbid Major Depressive Disorder or Dysthymic Disorder A Short-Term (Eight-Weeek) Open-Label Study, Ollowed by a Long-Term Evaluation, to Assess Patient-Reported Outcomes with XXX Treatment for Excessive Sleepiness in Adults with Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome. A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of XXX as Treatment for Adults with Residual Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea Syndrome A 12-Month, Open-Label, Flexible-Dosage Extension Study of the Safety and Efficacy of XXX in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder Updated 4/17/17 20

21 A Consumer Preference Study of the XXX All-in-One Positive Airway Pressure System on adult patients with Obstructive Sleep Apnea (OSA) A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Tolerability of XXX Treatment (150 mg) in Improving Clinical Condition Late in the Shift and in Improving Functional and Patient-Reported Outcomes in Adult Patients With Excessive Sleepiness Associated with Shift Work Disorder A 12 week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage, Study to Evaluate the Efficacy and Safety of XXX as Treatment for Patients with Excessive Sleepiness Associated with Mild or Moderate Closed Traumatic Brain Injury A Randomized, Double-Blind, Placebo-Controlled, Parallel, Proof of Concept Study to Evaluate the Effectiveness of XXX to Advance the Timing of Sleep in Individuals with Delayed Sleep Phase Syndrome (DSPS) A Phase III Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 12 Weeks of Study Drug XXX as Treatment for Adults with Excessive Sleepiness Associated with Chronic Shift Work Sleep Disorder (SWSD) Other Indications A Pivotal Trial IDE Medical Device. Targeted Hypoglossal Neurostimulation Study A Phase III, 24 week treatment, multicenter, randomized, double blinded, double dummy, parallel-group, clinical trial evaluating the efficacy and safety of XXX fixed-dose combination BID compared with each monotherapy A Phase III, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of XXX in patients with Uncontrolled Asthma who are on Inhaled Corticosteroids and a Second Controller Medication A Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to Evaluate the Effect of XXX on Long-term Cardiovascular Safety and COPD Exacerbations in Patients with Moderate to Very Severe COPD A Phase III, 28-Week, Multi-Center, Randomized, Double-Blind, Parallel-Group, Active- Controlled Safety Extension Study to Evaluate the Safety and Efficacy of XXX, XXX and XXX in Subjects With Moderate to Very Severe COPD, With XXX as an Active Control A Phase III, Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of XXX, XXX, and XXX in Subjects With Moderate to Very Severe COPD, Compared With Placebo and XXX as an Active Control Updated 4/17/17 21

22 A Phase III, Clinical Evaluation Of The Safety Of XXX When Administered Once Daily To Subjects With Spasticity Due To Multiple Sclerosis (MS): An Open Label, Long Term, Safety Trial A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily XXX in Children and Adolescents with Tourette s Disorder An Phase III Open-Label, Multicenter Study Evaluating the Safety and Tolerability of Oncedaily XXX in Children and Adolescents with Tourette s Disorder A Phase III Study to Assess Repeat Treatment Efficacy and Safety of XXX in Subjects with Irritable Bowel Syndrome with Diarrhea (IBS-D) A Phase IV Safety and Efficacy Study of Inhaled XXX Combination versus Inhaled XXX in the Treatment of Adolescent and Adult Subjects with Asthma A Placebo-Controlled Randomized Withdrawal Evaluation Of The Efficacy And Safety of XXX In Subjects With Spasticity Due To Multiple Sclerosis A Phase III, Six-month Randomized, Active Comparator, Open label, Multi-center Study to Evaluate Patient Outcomes, Safety and Tolerability of XXX in patients with Relapsing Remitting MS who are candidates for MS Therapy Change from previous Disease Modifying Therapy A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of XXX in Subjects with Opioid-Induced Bowel Dysfunction A Randomized, Double-blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of 2 Doses of XXX Compared With Placebo for 12 Weeks in Patients with Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease Followed by a 40-Week Evaluation of the 2 XXX Doses A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of XXX in Patients with Subjective Tinnitus AND an Open-Label, Long-Term Treatment Study to Assess the Long-Term Safety and Tolerability and Efficacy of XXX in Patients with Subjective Tinnitus A Three-Arm, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Efficacy, Safety and Tolerability of XXX for the Treatment of Adults with Stuttering An Eight -Week, Double Blind, Randomized, Multi-center, Flexible-Dose, Placebo Controlled Pilot Study of XXX in Patients with PDS Followed by a 52-Week Open-Label Extension Pharmacogenomics Blood Sampling Protocol for XXX Updated 4/17/17 22

23 SPEAKER S BUREAU AND PRESENTATIONS: Jazz Pharmaceutical National Advisory Board UCB Neupro Advisory Board Depomed Consultant, Boehringer-Ingelheim, GSK, (RLS) Member, Cephalon Advisory Panel, Sanofi National Speaker s Bureau, Forest Laboratories, Inc., 2009 Takeda, Sepracor, Sleep Disorders, Stroke and Heart Attack (El Paso Heart Conference 2009) Texas Advanced Nurse Practitioner Conference, 9/2008 Atlanta School of Sleep Medicine (San Antonio), Lecturer Sleep Disorders in Rehabilitation Setting (Brown Schools Annual Conf) Grand Rounds, Seton Medical Center, Insomnia, 2006 Grand Rounds, Heart Hospital, Sleep Disordered Breathing, Cardiovascular & Cerebrovascular Disease, 2006 USA Today National Hotline - Sleep Disorders, Ntl. Sleep Foundation (Washington, DC 2000, 2001) Sleep Disorders Interview, KTBC 2006, KXAN 2003 Stroke interviews, KKMJ and KVUE , 2006 Stroke Rehab (Puerto Rico Heart Assoc. / San Juan), 1998 Stroke Prevention (Marble Falls, Llano, Austin, Bastrop)/Brackenridge Hospital 9/ /2002 Grand Rounds Brackenridge Hospital, Austin Internal Medicine Society Parkinson s and Music Therapy (Cleveland, Ohio), 2000 Parkinson s Disease (McAllen, HealthSouth, Parkinson s Capital Area Society) SPECIAL HONORS: Brown Schools Rehab Center Physician of the Year (1994) Roger McCary Award for Physician Excellence 1997 Texas Medicine, Editorial Consultant Seton Hospital League House, Chairman of the Board, Texas Neurological Society, Past President Capital Area American Heart Association, President, , Austin, TX Health Initiative Leader, American Heart Association, Texas, 2003 Distinguished Service Award, American Heart Association, Texas 2002 AMA Physician Recognition Award ( ) Updated 4/17/17 23